Caplin, Martyn E., Pavel, Marianne, Ćwikła, Jaroslaw B., Phan, Alexandria T., Raderer, Markus, Sedlácková, Eva, Cadiot, Guillaume, Wolin, Edward M., Capdevila, Jaume, Wall, Lucy, Rindi, Guido, Langley, Alison, Martinez, Séverine, Blumberg, Joëlle and Ruszniewski, Philippe 2014. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. New England Journal of Medicine 371 (3) , pp. 224-233. 10.1056/NEJMoa1316158 |
Abstract
We conducted a randomized, double-blind, placebo-controlled, multinational study of the somatostatin analogue lanreotide in patients with advanced, well-differentiated or moderately differentiated, nonfunctioning, somatostatin receptor–positive neuroendocrine tumors of grade 1 or 2 (a tumor proliferation index [on staining for the Ki-67 antigen] of <10%) and documented disease-progression status. The tumors originated in the pancreas, midgut, or hindgut or were of unknown origin. Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide (Autogel [known in the United States as Depot], Ipsen) at a dose of 120 mg (101 patients) or placebo (103 patients) once every 28 days for 96 weeks. The primary end point was progression-free survival, defined as the time to disease progression (according to the Response Evaluation Criteria in Solid Tumors, version 1.0) or death. Secondary end points included overall survival, quality of life (assessed with the European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-GI.NET21), and safety.
Item Type: | Article |
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Date Type: | Publication |
Status: | Published |
Schools: | Medicine |
Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) |
Publisher: | Massachusetts Medical Society |
ISSN: | 0028-4793 |
Date of Acceptance: | 2014 |
Last Modified: | 31 May 2019 13:45 |
URI: | https://orca.cardiff.ac.uk/id/eprint/86699 |
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